Staff Regulatory Affairs Specialist (Remote)

We are currently seeking a Staff Regulatory Affairs Specialist to join our Neurovascular division. This position is based remotely anywhere in the United States.

As theStaff Regulatory Affairs Specialist you will support Strykers neurovascular devices. You will work to bring new medical devices to the market while ensuring ongoing compliance. You will participate on cross-functional teams develop global regulatory strategies author regulatory submissions and interact with regulatory agencies/notified bodies in major markets including the US EU Canada Japan China Australia Brazil and more.

What you will do

• Develop and execute regulatory strategies for pre-market products to achieve market access across global regions.
• Evaluate regulatory requirements and identify submission pathways for new products ensuring alignment with applicable regulations.
• Author and submit regulatory documents including FDA submissions and international dossiers to support product approvals.
• Assess global regulatory impact of product or process changes and coordinate required notifications or submissions.
• Partner with cross-functional teams to support regulatory agency interactions including responses meetings and documentation.
• Monitor regulatory intelligence and implement updates to strategies based on evolving global requirements.
• Maintain and update standard operating procedures to ensure compliance and improve regulatory processes.
• Provide regulatory guidance to stakeholders to align product lifecycle activities with applicable standards.

What you need

• Bachelors Degree (B.S. or B.A.)

• Minimum 4 years of experience in an FDA-regulated industry

• Minimum 2 years of experience in regulatory affairs

• Demonstrated applied knowledge of FDA and international medical deviceregulations/standards ( MDR)

Preferred

• Bachelors degree in engineering science or related field

• Regulatory Affairs Certification (RAC) or advanced degree in regulatory affairs or related discipline

• Experience with Class II or Class III medical devices

• Experience authoring 510(k) submissions or equivalent regulatory filings

• Experience interacting with regulatory agencies or supporting regulatory meetings

United States of America Pay Ranges:

• Puerto Rico: $77700 - $129500 USD Annual
• USN: $95700 - $159500 USD Annual
• US5: $100500 - $167500 USD Annual
• US10: $105300 - $175500 USD Annual
• US15: $110100 - $183400 USD Annual
• US20: $114800 - $191400 USD Annual
• US30: $124400 - $207400 USD Annual